[Translation] A randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of LQ3 tablets in healthy subjects
(1)主要目的:
评价LQ3片在中国健康成年受试者中单次和多次口服给药后的安全性和耐受性。
(2)次要目的:
评估LQ3片单次和多次口服给药后的药代动力学(PK)特征。
评估食物对中国健康成年受试者单次口服LQ3片的PK参数的影响。
(3)探索性目的:
探索LQ3片口服特定剂量后可能的代谢产物。
[Translation] (1) Primary objective:
To evaluate the safety and tolerability of LQ3 tablets after single and multiple oral administration in healthy Chinese adult subjects.
(2) Secondary objective:
To evaluate the pharmacokinetic (PK) characteristics of LQ3 tablets after single and multiple oral administration.
To evaluate the effect of food on the PK parameters of LQ3 tablets after single oral administration in healthy Chinese adult subjects.
(3) Exploratory objective:
To explore the possible metabolites of LQ3 tablets after oral administration of a specific dose.